Clinical trials: Open Surgery
Nephrectomy, Prostatectomy
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments…
- Trial name
- NCT06119568
- Testing
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Rob Surgical Systems S.L.
Parenchymous Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the…
- Trial name
- NCT01754480
- Testing
- Fibrin Sealant Grifols, Surgicel®
- Where
- 33 sites in United States, Hungary and 2 more
- Volunteers
- 325 people
- Sponsor
- Instituto Grifols, S.A.
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Breast Cancer
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: cannot be removed by an operation has spread to other parts of the body
- Trial name
- NCT03523585
- Testing
- Trastuzumab deruxtecan, Capecitabine, Lapatinib
- Where
- 227 sites in United States, Australia and 13 more
- Volunteers
- 608 people
- Sponsor
- Daiichi Sankyo
Colorectal Surgery
Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT03423485
- Testing
- CG-100 Intraluminal Bypass Device
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- Colospan Ltd.
Malignant Pleural Mesothelioma
Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants
This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery.
- Trial name
- NCT02004028
- Testing
- VS-6063
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Verastem, Inc.
Glaucoma, Glaucoma, Open Angle
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP)…
- Trial name
- NCT00382395
- Testing
- SOLX Gold Shunt GMS-plus, Ahmed FP7 Glaucoma Valve
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 180 people
- Sponsor
- SOLX, Inc.
Primary Open Angle Glaucoma (POAG)
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
- Trial name
- NCT02434692
- Testing
- ARGOS-IO system
- Where
- 11 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Glaucoma, Open-Angle
An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)
The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in…
- Trial name
- NCT04872348
- Testing
- OMNI® Surgical System
- Where
- 10 sites in United States
- Volunteers
- 28 people
- Sponsor
- Sight Sciences, Inc.
Atrial Fibrillation
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Lung Cancers
A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV)…
- Trial name
- NCT06713564
- Testing
- LS301-IT
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Integro Theranostics
Malignant Melanoma
Neoadjuvant L19IL2/L19TNF- Pivotal Study
Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.
- Trial name
- Pivotal (NCT02938299)
- Testing
- L19IL2 + L19TNF, Surgery
- Where
- 22 sites in France, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- Philogen S.p.A.
Otitis Media
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT01908764
- Testing
- AL-60371 otic suspension
- Sponsor
- Alcon Research
Astrocytoma, Brain Cancer
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers…
- Conditions
- Astrocytoma, Brain Cancer, Brain Metastases, Bladder Cancer
- Trial name
- NCT04430842
- Testing
- QBS10072S
- Where
- 2 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Quadriga Biosciences, Inc.
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Arthritis, Osteoarthritis, Knee
Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement
The study will describe the short-term effects the study drug, rivaroxaban, has on the body when a patient is switched from enoxaparin injection (by needle) to oral rivaroxaban (by mouth) for the prevention of blood clotting in…
- Conditions
- Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Thromboembolism
- Trial name
- NCT01094886
- Testing
- Rivaroxaban
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Lumbar Spinal Stenosis
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
- Trial name
- NCT01082159
- Testing
- lumbar decompression
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Vertos Medical, Inc.
Subjects With Primary Open-angle Glaucoma (POAG)
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.
- Trial name
- NCT01252888
- Testing
- iStents
- Where
- Armenia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Glaukos Corporation
Glioblastoma
Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma
Part 1 (dose escalation, safety, and preliminary efficacy) Part 1 is a non-randomised, single-arm design in 12 participants with recurrent GBM suitable for maximal safe surgical resection.
- Trial name
- OPTICAL (NCT07356973)
- Testing
- irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM
- Where
- United Kingdom
- Volunteers
- 147 people
- Sponsor
- CRISM Therapeutics LTD
Arthroplasty, Replacement, Knee
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or…
- Trial name
- AXIOMATIC-TKR (NCT03891524)
- Testing
- JNJ-70033093 25 mg, JNJ-70033093 50 mg, JNJ-70033093 100 mg
- Where
- 117 sites in United States, Argentina and 16 more
- Volunteers
- 1,242 people
- Sponsor
- Janssen Research & Development, LLC